Pertagen Adverse Reactions

Summary of the safety profile: As there is no other-monovalent pertussis vaccine available, Pertagen monovalent 2-component aP_gen and vaccines containing Pertagen components (TdaP_gen and DTaP_gen) were compared to 2, 3 or 5-components acellular pertussis-based vaccines (Tdap_chem and DTaP_chem).
The safety profile of Pertagen or vaccines containing Pertagen components (in quantity not less than in Pertagen) is based on the data from six randomized controlled trials in children, adolescents and adults including pregnant women (Table 4). Within 7 days after vaccination, the most common events occurring were local injection site pain (pain, redness and induration) and systemic reactions (headache, fatigue, myalgia, malaise and arthralgia).
The frequency, severity and duration of adverse events were similar in subjects vaccinated either with aP_gen-based vaccines or aP_chem-based comparator vaccines. These signs and symptoms were mostly mild and moderate in intensity and resolved without sequelae within a few days. (See Table 4.)

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Data from active pharmacovigilance of Pertagen (aP_gen) and Boostagen (TdaP_gen) also confirmed the safety profile of Pertagen in 11,429 individuals aged 11 years and above including 437 adolescents, 10,960 adults (including 1,778 pregnant women) and 32 elderly aged 65 years and above.